The Recall Desk
LowFDA (Devices)·Z-2374-2021·Announced 2021-09-08

Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates

Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is a voluntary administrative withdrawal involving labeling and instruction improvements. No safety defect, adverse events, injuries, or illnesses are reported in the source. Per the rubric, labeling updates and documentation improvements with no identified hazard constitute 'Low' severity.

Plain-English summary

Covidien, LP is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P from worldwide distribution to implement point-of-use labeling on each device and enhance the Instructions for Use.

The affected lot numbers are: 1729700119, 1817700205, 1910600266, 2014900148, 1810400147, 1828900137, 2014900151, and 2034400131.

Healthcare providers using devices from the affected lots should contact Covidien for guidance regarding the labeling updates and instruction enhancements to ensure proper device handling and use.

The recalled product

Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Manufacturer
Covidien, LP

Distribution

Distribution scope not specified by the agency.